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Spots Global Cancer Trial Database for LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

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Trial Identification

Brief Title: LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Official Title: LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Study ID: NCT00526305

Study Description

Brief Summary: Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.

Detailed Description: Remission Induction: * Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 * Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8. * Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14 * L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13 Results: 1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks 2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C Intrathecal chemotherapy: Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22 CONSOLIDATION TREATMENT 1 Start in two weeks after last dose of induction chemotherapy: * Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63 * Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56. * VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42 * ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43 * Intrathecal treatment, days 28 and 56. 6.4. CONSOLIDATION TREATMENT 2 Start in a week after last dose of mercaptopurine of previous cycle * Dexamethasone (DXM): * 10 mg/m2 day, p.o. or i.v. days 1-14 * 5 mg/m2 day, p.o. or i.v., days 15-21 * Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15 * Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9. * CFM 600 mg/m2 day, i.v., days 1 and 15 * L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17 * Intrathecal treatment days 1 and 15. TRANSPLANTATION Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment. Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1 Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Central de Asturias, Oviedo, Asturias, Spain

Hospital general de Castellón, Castello, Castellón, Spain

Hospital de Navarra, Pamplona, Navarra, Spain

Hospital Verge de la Cinta, Tortosa, Tarragona, Spain

Complejo Hospitalario Universitario de Albacete, Albacete, , Spain

Hospital General de Alicante, Alicante, , Spain

Hospital Ntra. Sra. Sonsoles, Avila, , Spain

Hospital de Badalona Germans Trias i Pujol, Badalona, , Spain

Hospital Clínic, Barcelona, , Spain

Hospital de Sant Pau, Barcelona, , Spain

Hospital del Mar, Barcelona, , Spain

Hospital vall d'Hebrón, Barcelona, , Spain

Basurtuko Ospitalea, Basurto, , Spain

Hospital de Cruces, Bilbao, , Spain

Hospital de Jerez de la Frontera, Jerez de La Frontera, , Spain

Complejo Hospitalario León, Leon, , Spain

Hospital Arnau de Vilanova, Lleida, , Spain

Complexo Hospitalario Xeral-Calde, Lugo, , Spain

Clínica Puerta de Hierro, Madrid, , Spain

Hospital 12 de Octubre, Madrid, , Spain

Hospital Clínico San Carlos de Madrid, Madrid, , Spain

Hospital de la Princesa, Madrid, , Spain

Hospital General Universitario Gregorio Marañón, Madrid, Madrid, , Spain

Hospital Universitario de la Princesa, Madrid, , Spain

Althaia, Xarxa Asistencial de Manresa, Manresa, , Spain

Hospital General Morales Meseguer, Murcia, , Spain

Hospital General Universitario Morales Meseguer., Murcia, , Spain

Hospital Santa María del Rosell, Murcia, , Spain

. Hospital Clínico Universitario Virgen de la Victoria, Málaga, , Spain

H. Carlos Haya, Málaga, , Spain

Complejo Asistencial Son Dureta, Palma de Mallorca, , Spain

Hospital Son Llatzer, Palma de Mallorca, , Spain

Clínica Universitaria de Navarra, Pamplona, , Spain

Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, , Spain

Corporació Sanitaria Parc Taulí, Sabadell, , Spain

Hospital de Sagunto, Sagunto, , Spain

Hospital Clínico Universitario de Salamanca, Salamanca, , Spain

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, , Spain

Hospital General de Segovia, Segovia, , Spain

H.U. Virgen del Rocio, Sevilla, , Spain

Hospital Universitario de Canarias, Tenerife, , Spain

Hospital Clínico Universitario de Valencia, Valencia, , Spain

Hospital Clínic, Valencia, , Spain

Hospital dr. Peset, Valencia, , Spain

Hospital General Universitario, Valencia, , Spain

Hospital La Fe, Valencia, , Spain

Hospital Clínico de Valladolid, Valladolid, , Spain

Complejo Hospitalario Universitario de Vigo, Vigo, , Spain

Hospital de Galdakao, Vizcaya, , Spain

Hospital Clínico Lozano Blesa, Zaragoza, , Spain

Contact Details

Name: Ribera Josep Mª, Dr

Affiliation: Germans Trias i Pujol Hospital

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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